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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P080009
Current Protocol Accepted 03/23/2015
Study Name OSB Lead-Open Label PAS of SEDASYS Syst User Resp
Study Status Terminated
Study Progress Reason Sponsor withdraws PMA, Dataset cannot address PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is designed to evaluate the SEDASYS┬« System can be used safely in routine   show the rest ...
Study Population Description Up to 32 users in up to 15 sites.
Sample Size Accounting for a 3% patient dropout, the resulting sample size will be 866.
Data Collection The primary endpoint will be the percentage of documented responses to alarms.

The secondary endpoint will   show the rest ...
Followup Visits and Length of Followup Duration of each subject's participation is approximately 2 days (one day participation and one day   show the rest ...

OSB Lead-Open Label PAS of SEDASYS Syst User Resp Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 11/01/2013 12/16/2013 Overdue/Received
one year report 05/03/2014 05/02/2014 On Time
18 month report 11/01/2014 10/30/2014 On Time
two year report 05/03/2015 04/23/2015 On Time
Final Report 06/03/2016 05/03/2016 On Time

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